BEUDAMED
    23 results · 21ms · Sources: EU EUDAMED, US FDA

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    NEUROMARK System (NMK00301)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Vivid ZirDisc Amman Girrbach System

    FDA UDI
    PEARSON DENTAL SUPPLIES, INC.·D724Q2500481·89x71x16mm SHT (Super Translucent)

    Vital Fresh Toothbrush

    FDA UDI
    SAFCO DENTAL SUPPLY CO.·10810063756212·Vital Fresh Toothbrush, imprinted, soft comfort...

    Stainless Steel Rectangular Wire

    FDA UDI
    Ortho Arch Company Inc·D90925004816·.017 x .022 STAINLESS STEEL RECTANGULAR 14' LEN...

    BIOGX SARS-COV-2 OSR FOR BD MAX SYSTEM

    FDA Adverse Event
    Malfunction ·BECTON, DICKINSON & CO.·Product code QJR·May 22, 2020

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197152754·Adapter for F/O Light carrier for Type L...

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011250048400·ceraMotion® Zr Dentin B3, 40 g / dental ceramic...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197152785·Fibre Optic Light Guide Cable Ø 4,8m...

    ceraMotion®

    FDA UDI
    DENTAURUM GmbH & Co.KG·J011250048200·ceraMotion® Zr Dentin B3, 20 g / dental ceramic...

    Evolve

    FDA UDI
    SIGNATURE ORTHOPAEDICS PTY LTD·09348215002534·

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197152761·Fibre Optic Light Guide Cable Ø 4,8m...

    RZ Medizintechnik GmbH

    FDA UDI
    RZ-Medizintechnik GmbH·04049197152778·Fibre Optic Light Guide Cable Ø 4,8m...

    KC500 48 X 48 WRAP, 500 STRAND

    FDA Adverse Event
    Injury ·KIMBERLY CLARK·Product code FRG·August 4, 2014

    HOFFMAN II MICRO EXTERNAL FIXATION SYSTEM

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    MectaLIF Anterior Simple

    FDA 510(k)
    FDA Class 2 ·Orthopedic

    CASHMERE 14 - CERECYTE MICROCOIL

    FDA Adverse Event
    Malfunction ·CODMAN AND SHURTLEFF, INC·Product code HCG·November 14, 2014

    PARADIGM REAL-TIME REVEL INSULIN INFUSION PUMP

    FDA Adverse Event
    Injury ·MEDTRONIC MINIMED·Product code MDS·September 9, 2011

    SIGMA STAB GVF INS 3 10MM

    FDA Adverse Event
    Injury ·JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD·Product code JWH·July 26, 2013

    Venclose digiRF Generators, Model VCRFG1, with software 3.35 designed to identify internal wiring anomalies in the Venclose EVSRF Ablation Catheter prior to use. The Venclose digiRF Generator is a sophisticated multi-voltage energy delivery system featuring touchscreen control that automatically configures non-adjustable treatment parameters (including time and temperature) for compatible catheters connected via a triaxial connector port. Designed for use with Venclose RF Catheters (either the EVSRF or Maven variants) as an integrated system, the device employs resistive radiofrequency ablation to deliver temperature-controlled RF energy that heats incompetent vein walls, inducing irreversible luminal occlusion followed by progressive fibrosis and eventual vein resorption. The 510(k) submission K250068 encompasses solely the Venclose digiRF Generator due to software modifications with no alterations to the cleared Venclose Catheters (EVSRF and Maven variants, cleared under K160754 and K211806, respectively).

    FDA Enforcement
    Class II ·Ongoing·Bard Peripheral Vascular Inc·October 8, 2025

    Impella catheters - Intravascular micro axial blood pumps that support a patient's circulatory system. (1) Product Code 005042 - Impella 2.5 (2) Product Code 005062 - Impella 5.0 (3) Product Code 005082- Impella LD (4) Product Code 004334 - Impella RP (5) Product Code 0046-0035 - Impella RP with SmartAssist (6) Product Code 1000323 - RP Flex with SmartAssist (7) Product Codes 0550-0008 and 1000100 - Impella 5.5 with SmartAssist (8) Product Code 0048-0032 - Impella CP (9) Product Codes 100080 and 0048-0045 - Impella CP with SmartAssist -- ***Added 2/20/24*** (10) 4413 and 004413 - Impella 2.5 Set (11) 5040 and 005040 - Impella 2.5 IMC Pump Set EU (12) 5060 and 005060 - Impella 5.0 IMC Pump Set EU (13) 5064 and 005064 - Impella 5.0 IMC Pump Set Canada (14) 1000115 - Impella CP Pump set, APAC (15) 1000211 - Impella 5.5 Smart Assist Set, JP (16) 1000302 - Impella CP with SmartAssist APAC (17) 1000361 - Impella 5.5 Set AU (18) 1000402 - Impella CP Smart Assist Set (19) 0046-0011 - Impella RP Pump Set, EU (20) 0046-0026 - Impella 5.0 Pump Set ROW (21) 0046-0037 - Impella 5.0 Pump Set APAC (22) 0046-0039 - Impella RP Set APAC (23) 004690-AU - Impella 5.0 Pump Set AU (24) 0048-0002 - Impella CP Pump Set, EU (25) 0048-0002-BR - Impella CP Pump Set BR (26) 0048-0004 - Impella CP Pump Set, Canada (27) 0048-0014 - Impella Smart Assist Set, EU (28) 0048-0024-JP - Impella CP Smart Assist Set, JP (29) 0048-0044 - Impella CP Smart Assist Set, Canada (30) 0048-0047- Impella CP Smart Assist Set APAC (31) 005048-JP - Impella 2.5 Pump Set, Japan (32) 005066-JP - Impella 5.0 Pump Set, Japan (33) 0550-0002 - Impella 5.5 with SmartAssist Set, EU (34) 0550-0004 - Impella 5.5 with SmartAssist Set, CA

    FDA Enforcement
    Class II ·Ongoing·Abiomed, Inc.·February 21, 2024